The Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS) is the regulatory agency that oversees the quality, safety and efficacy of pharmaceuticals and medical devices in Spain. It was founded in 1999 to replace the Spanish Pharmacy and Medical Devices Administration (Dirección General de Farmacia y Productos Sanitarios) and the Spanish Centre for Pharmacobiology (Centro Nacional de Farmacobiologia), its activities being established under Law 29/2006 of 26th of July.
The agency within the Ministry of Health and Social Policy authorizes and controls medicines for human and veterinary use, cosmetics, medical devices, hygiene products and clinical trials as well as oversees supply and access and serves. Apart from overseeing publish health in Spain, the AEMPS is the certifying authority for medical devices in the EU, acting as a representative of the European agencies’ network and the European Medicines Agency.
Some of the most important European regulations for medical devices in the EU are:
- CONSOLIDATED Medical Device Directive (93/42/EEC)
- CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
- View as web page
- Personal Protective Equipment Directive (89/686/EEC)
A full list of EU regulations can be found here.
- Website: http://www.msssi.gob.es/en/home.htm
Medical Device Associations in Spain: